Reduced-dose Carboplatin-doublet-chemotherapy + Cemiplimab vs Cemiplimab Monotherapy in Treatment Naive Older and Frail Patients With Metastatic NSCLC With PD-L1 <50%

Sponsor
Swiss Cancer Institute
Study ID
NCT07020065
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic NSCLC - Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — DRUG
    cemiplimab IV 350 mg, day 1
  • Carboplatin — DRUG
    carboplatin IV AUC 3 day 1
  • Pemetrexed & Gemcitabine — DRUG
    pemetrexed IV 300 mg/m2 day 1 gemcitabine IV 600 mg/m2 day 1, d8
  • Paclitaxel — DRUG
    paclitaxel IV 50 mg/m2 day 1, d8

Study Details

Metastatic non-small cell lung cancer is often treated with a combination of chemotherapy and immunotherapy. In patients over the age of 70, some are already in poor health and frail, requiring assistance with daily activities, for example. Older and/or frail individuals often do not tolerate standard-dose chemotherapy well, and their risk of side effects is higher than that of younger patients. For this reason, the SAKK 18/24 study is investigating how effective and safe chemotherapy is in patients over 70 years of age when the chemotherapy drugs are administered at lower doses than usual. The aim of the study is to find a potentially effective and well-tolerated treatment for older people with metastatic non-small cell lung cancer.

Key Dates

Start date
Apr 10, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2030

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental arm
    Non-squamous histology: * carboplatin IV AUC 3 day 1 * pemetrexed IV 300 mg/m2 day 1 * cemiplimab IV 350 mg, day 1 Every 3 weeks, for 4 cycles, followed by maintenance treatment with cemiplimab with or without pemetrexed (at same dose and interval as above). Squamous histology: * carboplatin IV AUC 1.5 day 1, d8 * gemcitabine IV 600 mg/m2 day 1, d8 * cemiplimab IV 350 mg, day 1 Every 3 weeks, for 4 cycles, followed by maintenance treatment with cemiplimab (350 mg q3w) Any histology: * carboplatin IV AUC 1.5 day 1, d8 * paclitaxel IV 50 mg/m2 day 1, d8 * cemiplimab IV 350 mg, day 1 Every 3 weeks, for 4 cycles, followed by maintenance treatment with cemiplimab (350 mg q3w)
  • Active Comparator: Comparator arm
    cemiplimab IV 350 mg, day 1 Every 3 weeks (max. 2 years)

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: From the date of randomization until the date of confirmed tumor progression according to RECIST 1.1 or death from any cause, assessed up to 1 year after end of treatment. ]

Central Contacts

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